Back to resultsSafety, Tolerability, and Pharmacokinetics of CSX-1004
Primary Purpose
Opioid Overdose, Opioid Use Disorder
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CSX-1004
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Overdose
Eligibility Criteria
Major Inclusion Criteria: Healthy male or female subjects, aged 18 to 50 years, inclusive, Minimum weight of 50.0 kg and maximum weight of 100.0 kg Body mass index (BMI) within the range of 18.0 to 32.0 kg/m2, inclusive Major Exclusion Criteria: Positive UDS for substances of abuse (including alcohol) at Screening or admission to the Treatment Phase Current daily cigarette smoker within 3 months of Screening. Social smoking, as defined by non-daily use of nicotine-containing products, is permitted. History or presence of any clinically significant cardiac, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease or illness at Screening, which in the opinion of the Investigator, might jeopardize the safety of the subject or the validity of the study results.
Sites / Locations
- Dr. Vince Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CSX-1004
Placebo
Arm Description
Single doses of CSX-1004 Injection
Sterile saline for injection
Outcomes
Primary Outcome Measures
Treatment-emergent adverse events (AEs), serious AEs, and AEs leading to discontinuation
Incidence, intensity, and causality of adverse events
Clinical laboratory assessments
Hematology, biochemistry, and urinalysis
Vital signs
Blood pressure and pulse rate
12-Lead electrocardiogram
Variables will include ventricular heart rate and the PR, QRS, QT, QTcB and QTcF intervals
Physical examination
Complete physical examination, assessing the subject's overall health and physical condition
Infusion site examination
Infusion site will be visually inspected for evidence of erythema, edema, itching, pain, infection, bleeding, abnormal healing, and any other abnormalities
Secondary Outcome Measures
Cmax
Maximum serum concentration
AUCinf
Area under the curve from time zero extrapolated to infinity
AUClast
Area under the curve from time zero to the last measurable concentration
Tmax
Time to maximum serum concentration
t1/2
beta terminal elimination half-life
Full Information
NCT ID
NCT06005402
First Posted
August 4, 2023
Last Updated
August 17, 2023
Sponsor
Cessation Therapeutics, Inc.
Collaborators
Dr. Vince Clinical Research
1. Study Identification
Unique Protocol Identification Number
NCT06005402
Brief Title
Safety, Tolerability, and Pharmacokinetics of CSX-1004
Official Title
A Phase 1a, Randomized, Double-Blind, Placebo-Controlled, Single Site, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of CSX-1004 Injection in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cessation Therapeutics, Inc.
Collaborators
Dr. Vince Clinical Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion across a range of doses in healthy adult subjects. The study will have 3 phases: Screening, Inpatient Treatment, and Outpatient Follow-up.
The primary objective of the study is to determine the safety and tolerability of CSX-1004 Injection administered by intravenous (IV) infusion across a range of doses in healthy adult subjects.
The secondary objective of the study is to determine the pharmacokinetics (PK) of CSX-1004 Injection administered by IV infusion across a range of doses in healthy adult subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Overdose, Opioid Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Single ascending dose study
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CSX-1004
Arm Type
Experimental
Arm Description
Single doses of CSX-1004 Injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sterile saline for injection
Intervention Type
Biological
Intervention Name(s)
CSX-1004
Intervention Description
Recombinant human immunoglobulin G (IgG) 1λ monoclonal antibody specific for fentanyl and structurally related fentanyl analogs
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Sterile saline for injection
Primary Outcome Measure Information:
Title
Treatment-emergent adverse events (AEs), serious AEs, and AEs leading to discontinuation
Description
Incidence, intensity, and causality of adverse events
Time Frame
5 months
Title
Clinical laboratory assessments
Description
Hematology, biochemistry, and urinalysis
Time Frame
5 months
Title
Vital signs
Description
Blood pressure and pulse rate
Time Frame
5 months
Title
12-Lead electrocardiogram
Description
Variables will include ventricular heart rate and the PR, QRS, QT, QTcB and QTcF intervals
Time Frame
5 months
Title
Physical examination
Description
Complete physical examination, assessing the subject's overall health and physical condition
Time Frame
5 months
Title
Infusion site examination
Description
Infusion site will be visually inspected for evidence of erythema, edema, itching, pain, infection, bleeding, abnormal healing, and any other abnormalities
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Cmax
Description
Maximum serum concentration
Time Frame
4 months
Title
AUCinf
Description
Area under the curve from time zero extrapolated to infinity
Time Frame
4 months
Title
AUClast
Description
Area under the curve from time zero to the last measurable concentration
Time Frame
4 months
Title
Tmax
Description
Time to maximum serum concentration
Time Frame
4 months
Title
t1/2
Description
beta terminal elimination half-life
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Immunogenicity
Description
Proportions of subjects who are positive (above the limits of quantitation) and negative (below the limits of quantitation) for anti-CSX-1004 antibodies
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Major Inclusion Criteria:
Healthy male or female subjects, aged 18 to 50 years, inclusive,
Minimum weight of 50.0 kg and maximum weight of 100.0 kg
Body mass index (BMI) within the range of 18.0 to 32.0 kg/m2, inclusive
Major Exclusion Criteria:
Positive UDS for substances of abuse (including alcohol) at Screening or admission to the Treatment Phase
Current daily cigarette smoker within 3 months of Screening. Social smoking, as defined by non-daily use of nicotine-containing products, is permitted.
History or presence of any clinically significant cardiac, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease or illness at Screening, which in the opinion of the Investigator, might jeopardize the safety of the subject or the validity of the study results.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brandi Eckard
Phone
913-333-3000
Email
breckard@drvince.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lora Adriano
Phone
913-333-3000
Email
ladriano@drvince.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Hull, MD
Organizational Affiliation
Dr. Vince Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Vince Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandi Eckard
Phone
913-333-3000
Email
breckard@drvince.com
First Name & Middle Initial & Last Name & Degree
Lora Adriano
Phone
913-333-3000
Email
ladriano@drvince.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety, Tolerability, and Pharmacokinetics of CSX-1004
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